FDA Adverse Event
Malfunction
Summary report: N
FLOGARD
MDR report key: 4252302
·
Received November 14, 2014
Report
- Report Number
- 1416980-2014-40772
- Event Type
- Malfunction
- Date Received
- November 14, 2014
- Date of Event
- October 21, 2014
- Report Date
- October 21, 2014
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION SUMMARY: THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. VISUAL INSPECTION, FUNCTIONAL TESTING, AND A REVIEW OF THE ALARM LOG WERE PERFORMED. THE DAMAGED DOOR WAS IDENTIFIED DURING VISUAL INSPECTION. THE CAUSE OF THE CONDITION WAS UNABLE TO BE DETERMINED. TO CORRECT THE CONDITION, THE LATCH ROLLER AND DOOR LATCH WERE REPLACED. THE DEVICE WAS SERVICED TO MEET FUNCTIONAL SPECIFICATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING PRODUCT SERVICE BY A SERVICE TECHNICIAN, A FLOGARD INFUSION PUMP WAS FOUND TO HAVE A DAMAGED DOOR. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736014 | FLOGARD | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |